Disclosure, Apology, and Offer Programs: Stakeholders Views of Barriers to and Strategies for ...

24 Pages·2012·0.49 MB·English

THE
MILBANK QUARTERLY
A MULTIDISCIPLINARY JOURNAL OF POPULATION HEALTH AND HEALTH POLICY
Disclosure, Apology, and Offer Programs:
Stakeholders’ Views of Barriers to and
Strategies for Broad Implementation
SIGALL K. BELL,1 PETER B. SMULOWITZ,1
ALAN C. WOODWARD,2 MICHELLE M. MELLO,3
ANJALI MITTER DUVA,1 RICHARD C.
BOOTHMAN,4 and KENNETH SANDS1
1BethIsraelDeaconessMedicalCenterofHarvardMedical
School;2MassachusettsMedicalSociety;3HarvardSchoolofPublic
Health;4UniversityofMichiganHealthSystem/UniversityofMichigan
MedicalSchool
Context: The Disclosure, Apology, and Offer (DA&O) model, a response to
patient injuries caused by medical care, is an innovative approach receiving
nationalattentionforitsearlysuccessasanalternativetotheexistinginherently
adversarial, inefficient, and inequitable medical liability system. Examples of
DA&Oprograms,however,arefew.
Methods: Through key informant interviews, we investigated the potential
for more widespread implementation of this model by provider organizations
and liability insurers, defining barriers to implementation and strategies for
overcoming them. Our study focused on Massachusetts, but we also explored
themesthatarebroadlygeneralizabletootherstates.
Findings: We found strong support for the DA&O model among key stake-
holders,whociteditsbenefitsforboththeliabilitysystemandpatientsafety.
The respondents did not perceive any insurmountable barriers to broad im-
plementation, and they identified strategies that could be pursued relatively
quickly. Such solutions would permit a range of organizations to implement
themodelwithoutlegislativehurdles.
Addresscorrespondenceto: SigallK.Bell,BethIsraelDeaconessMedicalCenter,
DivisionofInfectiousDiseases,110FrancisSt.LMOB-GB,Boston,MA02215
(email:[email protected]);PeterB.Smulowitz,BethIsraelDeaconess
Medical Center, Department of Emergency Medicine, One Deaconess Road,
WCC2,Boston,MA02215(email:[email protected]).
TheMilbankQuarterly,Vol.90,No.4,2012(pp.682–705)
(cid:2)c 2012MilbankMemorialFund.PublishedbyWileyPeriodicalsInc.
682
Disclosure,Apology,andOfferPrograms 683
Conclusions: Although more data are needed about the outcomes of DA&O
programs,themodelholdsconsiderablepromisefortransformingthecurrent
approachtomedicalliabilityandpatientsafety.
Keywords: Medicalliability,malpractice,patientsafety,disclosure,apology,
compensation.
I
njuries to patients caused by medical care continue to
bedevil both patients and the medical community. The current
medical liability system presents critical barriers to improving pa-
tient safety, ensuring fair and reasonable resolutions to medical injury
disputes, and controlling the cost of health care nationwide (Studdert,
Mello, and Brennan 2004). The negative consequences of the medical
liabilitysystemhavebeenwelldocumented(KachaliaandMello2011).
Litigation is inherently adversarial, threatening the therapeutic rela-
tionship between patient and provider. Only about 2 to 3 percent of
patientsharmedbynegligencepursuelitigation,andonlyabouthalfof
these receive compensation (Localio et al. 1991; Studdert et al. 2006).
Litigation is a protracted process, taking an average of five years from
thetimeofinjurytoclaimresolution(Studdertetal.2006).Theprocess
also takes a great emotional toll on patients and doctors alike (Cantor
et al. 2005; Delbanco and Bell 2007; Waterman, Garbutt, and Hazel
2007; West et al. 2006). Furthermore, the tort system does not effec-
tivelydistinguishbetweenindividualandsystemicerrors(Reason2000),
and blame is often unnecessarily placed on the health care provider for
multifactorial errors far out of his or her control (Hiatt et al. 1989;
Mello and Studdert 2008). Concerns about liability inhibit physicians’
effortstoimprovepatientsafetyandmotivatethemtopracticedefensive
medicine. As a result, they order medically unnecessary tests or avoid
treating high-riskpatients. Theseproblems areperpetuatedas medical
students and trainees learn such practices early in their careers (Bren-
nan, Mello, and Studdert 2006; Kessler and McClellan 1996; Mello
et al. 2005; O’Leary et al. 2012; Studdert et al. 2005). The critical
flowofinformationneededtoimprovethesesystemsishinderedbythe
secrecy and fear that surround bad outcomes (Boothman et al. 2009;
MassachusettsMedicalSociety2008).
Professional organizations, patient advocacy groups, and ethicists
have long agreed that patients have the right to full disclosure of
684 S.K.Belletal.
unanticipated care outcomes (American Society for Healthcare Risk
Management of the American Hospital Association 2003; American
Hospital Association Management Advisory Committee 1992; Banja
2001; Institute of Medicine 2001; Wu et al. 1997). Yet patients likely
learnaboutonlyathirdofallmedicalerrors(Blendon,DesRoches,and
Brodie 2002; Kaiser Family Foundation 2004), and even when errors
aredisclosed,theconversationoftenfailstomeetpatients’expectations
(Gallagheretal.2003).Thelackofopencommunicationandanapology
after harmful events erodes trust, hinders patient care, and fuels litiga-
tion(Vincent,Young,andPhillips1994).Italsopreventsprovidersand
institutions from assuming appropriate accountability and improving
patientsafety(Sage2003).
In conjunction with disclosure, health care organization leaders are
increasingly recognizing that a pervasive culture of individual blame
substantiallylimitstheircapacitytoimprovepatientsafetyandclinical
outcomes. Accordingly, organizations are now turning to developing
a “just culture” that seeks the root causes of medical errors and pro-
motesanonpunitiveculture(Marx2001).Ratherthaneliminatingthe
responsibility of the individual or organization when errors occur, this
approachexaminesbothindividualandsystems-levelfactors,allowsfor
greatercandor,andencouragesindividualstoparticipateinsystems-level
harm prevention and remediation (Clarke, Lerner, and Marella 2007;
Connoretal.2007;Khatri,Brown,andHicks2009;Khatrietal.2007;
Marx2001).
TheDisclosure,Apology,andOffer(DA&O)modelemphasizesboth
honestcommunicationwithpatientsandfamiliesandasystemsapproach
toerrors.Itpromotesaprincipledinstitutionalresponsetounanticipated
clinicaloutcomesinwhichhealthcareorganizations(1)proactivelyiden-
tify adverse events, (2) distinguish between injuries caused by medical
negligence and those arising from complications of disease or intrinsi-
callyhigh-riskmedicalcare,(3)offerpatientsfulldisclosureandhonest
explanations, (4) encourage legal representation for patients and fami-
lies, and (5) offer an apology with rapid and fair compensation when
standards of care were not met (table 1). Patient safety interests are
better served when errors are captured and handled without protracted
litigation,allowingtheinstitutionandclinicianto concentrateinstead
onhelpingthepatientandturninglessonslearnedintosafetyimprove-
ments. Making whole those patients who have been harmed through
medical negligence as quickly and fairly as possible after a harmful
Disclosure,Apology,andOfferPrograms 685
TABLE1
CharacteristicsoftheDisclosure,Apology,andOfferModel
ActionsTakenbyHospitaland
Objective LiabilityInsurer
Increasetransparencyregardingadverse (cid:129)Discloseadverseoutcomesofcare
outcomesandsupportphysiciansin topatientsandfamilies.
disclosingadverseoutcomesto (cid:129)Investigateviaroot-causeanalysis
patients. andexplainwhathappened.
(cid:129)Provideanapologywhen
appropriate.
Improvepatientsafety. (cid:129)Implementsystemstoavoid
recurrenceofincidents,using
informationfromcasesofmedical
injuryandnearmissestoidentify
safety-enhancinginterventions
andworkingwithhospitalstaffto
implementthem.
Avoidlawsuits,reduceliabilitycosts, (cid:129)Offerfinancialcompensation
andimproveaccesstocompensation whencarewasunreasonable,
bymeetingthefinancialneedsof withoutthepatienthavingtofile
injuredpatientsandtheirfamilies alawsuit.
quicklyandfairlyintheaftermathof (cid:129)Defendcasesvigorouslywhencare
aninjury. wasreasonable.
errordiminishesanyconflictsofinterestonthepartofthephysicianor
the institution to help the patient while avoiding litigation and helps
preservetherapeuticrelationshipsbetweenpatientsandcaregivers.The
model also enables institutions to focus on protecting future patients
from the same experience (Boothman et al. 2009; Kachalia, Kaufman,
and Boothman 2010; Kraman and Hamm 1999; Mello and Gallagher
2010).
Todate,DA&Omodelshavebeenimplementedprimarilybyasmall
number of self-insured (captive) hospital systems—the University of
Michigan the best-described program—and relatively little data exist
aboutthemodel’slikelyeffectsinmorediverseenvironments(Kachalia
and Mello 2011). The success of DA&O models in achieving the
dual goals of promoting patient safety improvements and reducing
malpractice costs, however, has garnered support from the Agency
for Health Care Quality and Research (AHRQ), the Joint Commis-
siononAccreditationofHealthCareOrganizations,andothernational
686 S.K.Belletal.
organizations (Joint Commission on Accreditation of Health Care Or-
ganizations 2005). Nevertheless, relatively few hospital systems and
insurershaveadoptedthismodel.
The University of Michigan Health System began in late 2001 and
early 2002 what has since been called the disclosure, apology and offer
(DA&O) model for responding to patient injuries caused while render-
ingmedicalcare. Initially usingthe opportunity offeredby Michigan’s
compulsory preliminary notice of intent to sue (required before any
Michigan medical malpractice case can be filed) (Michigan Compiled
Laws §600.2912b [1994]), unanticipated clinical outcomes are now
identified quickly in an increasingly vigilant institutional culture via
various means, including voluntary electronic incident reports, patient
complaints,caregiverreports,andproactivedatapullsofinternallyde-
rived patient safety indicators. While the process is tailored to each
individual case, patients and families are generally contacted by risk
management consultants, who ensure that new clinical care needs are
met,overseethehospital’sinvestigation,reviewpatients’andproviders’
expectations,andensurefulldisclosure(Boothmanetal.2009).Patients
and families are kept informed, receive full disclosure, and also receive
an apology, with an offer of compensation when appropriate (Booth-
manetal.2009,Boothman,Imhoff,andCampbell2012).Theprogram
is directly linked to the patient safety and peer review infrastructure
that dominates the overriding institutional focus. The Michigan pro-
gram’sclaimsexperiencewasreportedinabefore-and-afterexamination,
whichdocumentedsignificantimprovementsinclaimsfrequency,trans-
actionalcosts,incidenceoflitigation,andtime-to-resolution(Kachalia,
Kaufman,andBoothman2010).Moreover,thesereportsfoundthatcul-
turally,thefocushadshiftedtosafety,pushingmedicalmalpracticeinto
thebackground(Boothman,Imhoff,andCampbell2012).
In July 2010, the AHRQ awarded approximately $23 million in
grantsforapproachestomedicalinjurycompensationthatalsoimprove
patient safety (AHRQ 2010a). Four of the demonstration projects fo-
cused on expanding the DA&O program in use at the University of
MichiganHealthSystem(AHRQ2010b),signalingnationalinterestin
thismodel.
As part of a planning grant from this AHRQ program, we exam-
ined the prospects for more widespread implementation of the DA&O
model.Althoughsomecommentatorshavesuggestedfactorsthatmight
account for this model’s lack of widespread dissemination, particularly
Disclosure,Apology,andOfferPrograms 687
in settings other than self-insured academic medical centers, this issue
has not been empirically investigated previously (Localio 2010; Mello
and Gallagher 2010; Mello and Kachalia 2011; Peto et al. 2009). We
conducted a key informant interview study of stakeholders concerning
theirperceptionsoftheDA&Omodel,perceivedbarrierstoimplemen-
tation, and strategies for overcoming them. While our study centered
on Massachusetts, we explored themes that are generalizable to other
states.
Methods
We conducted semistructured interviews with twenty-seven individu-
als in leadership positions in organizations or constituencies central to
implementingtheDA&OapproachinMassachusetts.Weusedathree-
stageselectionprocess,inwhichthestudyteammembersfirstidentified
major categories of stakeholder groups (e.g., liability insurers and pa-
tientadvocacygroups),thenidentifiedleadingorganizationsinthestate
ineachcategory,and,last,identifiedanindividualineachorganization
whoeitherheldatopleadershiproleorhadexpertiseinlegalandgov-
ernment affairs. We intended to capture a broad range of perspectives
and to interview that person in each organization who knew the most
aboutthepotentialbarrierstoadoptingaDA&Omodel.
Three physician-investigators, working in teams of two (with the
exception of a single interview conducted by one interviewer), led the
interviews, which lasted forty-five to sixty minutes. The interviewers
used an interview guide that was pretested on two respondents not in-
cludedintheanalyticalsample.Theinterviewguidecoveredfourmain
areas:(1)therespondent’sinstitutionalsettingandrelevantexperience,
(2)perceivedpotentialfortheDA&Omodeltoimprovemedicalliability
and patient safety, (3) perceived barriers to implementing DA&O pro-
grams, and (4) suggested strategies for overcoming identified barriers.
Eachinterviewwasdigitallyrecordedandprofessionallytranscribed.The
projectwasreviewedbytheinstitutionalreviewboardsoftheBethIsrael
DeaconessMedicalCenterandtheHarvardSchoolofPublicHealth.
Weanalyzedthetranscriptsusingmethodsofthematiccontentanal-
ysis(GlaserandStrauss1967).Wedevelopedacodingschemeofinter-
viewtopicsafterreadingarandomsampleoftranscripts,definingeach
coding category in a detailed coding manual. One interviewer then
688 S.K.Belletal.
TABLE2
InterviewRespondentAffiliations(n=27)
StakeholderGroup NumberofRespondents
Stateagenciesandlegislature 6
Hospitalsystems:
Academicmedicalcenters 2
Communityhospitals 2
Practicingphysicians 3
Liabilityinsurers 2
Healthinsurers 2
Medicalprofessionalassociations 2
Patientadvocacyorganizations 2
Malpracticeattorneys 2
Patientsafetyexperts 2
Majorphysicianpracticegroups 1
Businessassociations 1
coded each transcript, entering data into Microsoft Excel. Another in-
vestigator then compared the interview responses in each category to
find emerging themes. For some questions, response frequencies were
also tabulated. We then compiled and vetted the preliminary report,
firstwiththeinterviewrespondentsforindividualfeedback,andsecond
at a meeting with a larger group of approximately 180 stakeholders,
structuredtoensurethatallviewpointsweresolicited.
Results
The interview respondents represented a broad range of stakeholder
groups in Massachusetts (table 2). Of the twenty-eight stakeholder
groups in the original sampling frame, twenty-seven were interviewed
(96%).Twoindividualsfromtheoriginalinvitationlistdidnotrespond;
onewasreplacedwithastakeholderofsimilarbackground,andtheother
did not have a specific replacement. The remaining invitees agreed to
beinterviewedorprovidedadelegate.Overall,nineofthetwenty-seven
(30%)respondentswerephysicians.Bothmajormalpracticeinsurersin
the state were included, as were several smaller self-insured hospital
systems.
Disclosure,Apology,andOfferPrograms 689
TABLE3
AppealingAspectsoftheDA&OModel
ElementCited %(n)
Ethicalandprofessionalconsiderations 89(24/27)
Reduceslegalriskandcosts 74(20/27)
Improvessafetycultureinhospital 56(15/27)
Improvesdisputeresolutionprocess 37(10/27)
Servespatients’needsbetter 37(10/27)
Pragmaticconsiderations(e.g.,feasible,politically 11(3/27)
salable,wouldmakehospitallookgood)
Appeal of the DA&O Model
Asked what aspects, if any, of the DA&O model they found appealing,
therespondentsmostfrequentlycitedethicalandprofessionalconsider-
ations(table3),includingopenandcompassionateresponsestomedical
injuries. As a hospital representative pointed out, “The appealing part
would be that it’s the right thing to do, that it removes all those le-
gal curtains, the discomfort and the barriers that make it hard to have
a conversation with someone and just say, ‘We’re sorry we hurt you.
We want to make it right for you.’” The potential for reduced legal
costs was another prospect that the respondents found appealing. Oth-
ersemphasizedthatthemodelwascentraltoimprovingsafetyculture.
A state official remarked, “It encourages learning. It encourages pre-
venting the next problem so you’re not just covering something up.
You’re saying, ‘Let’s really look at what happened. Let’s get it out in
the open and let’s have a good conversation.’ Then the next time, it’s
less likely to happen.” Summing up these impressions, one respondent
called the model “a huge win for patients, [who] suffer as much as
anybody in the courts, maybe more. It’ll be a huge win for providers
emotionally. It will be a huge win from a financial perspective because
therightpeoplewillbegettingcompensatedinamoretimelymanner
and there will be far less waste in the process.” Finally, pragmatic con-
siderationswerementionedasadditionalbenefits,forexample,thatthe
DA&Omodelwouldbefeasibleandevenpopularinanenvironmentin
which political gridlock has precluded the legislative adoption of tort
reforms.
690 S.K.Belletal.
Alternative Approaches
Themajorityofrespondentsfeltthatforimprovingthemedicalliability
and patient safety environments in Massachusetts, no alternative held
greaterpromisethantheDA&Omodel.Thoserespondentswhooffered
alternativesprimarilydiscussedcomplementarystrategieslikeamanda-
toryprelitigationreviewperiodor,forcasesnotresolvedbytheDA&O
model,expertwitnessstandards,capsonnoneconomicdamages,orthe
useofhealthcourts.
Barriers to Implementing the DA&O Model
and Strategies for Overcoming Them
Ourinterviewsrevealedseveralbarrierstothewidespreadimplementa-
tion of the DA&O model (table 4) and also strategies for surmounting
them.Herewesummarizethemostcommonlycitedbarriersandsolu-
tions.Later,inourdiscussion,weevaluatetherelativesignificanceofthe
barriers in light of the feasibility of the suggested solutions. With the
exception of charitable immunity, all the barriers cited here are issues
thattranscendtheMassachusettscontext.
Charitable Immunity. At the time of this study, Massachusetts law
limitedto$20,000thetortliabilityofanycharitablecorporation,trust,
or association (which includes nonprofit hospitals and health care in-
stitutions) (Mass. Gen. Laws Ann. ch. 231, § 85K [2012]). This law
coversnearlyallhospitalsinMassachusetts.Ourrespondentsmentioned
thislawmoreoftenthananyotherbarriertoimplementingtheDA&O
model,notingthathospitals’limitedfinancialresponsibilityformedical
injuriesmayundercuttheirinterestinliabilityreformandincentivesfor
investmentinpatientsafety.Thestakeholdersalsoworriedthatbecause
physicians are the “deep pockets” in the current system, they may be
reluctanttoparticipateindisclosure.
The stakeholders agreed that fundamental changes to the charitable
immunity law, which applies to all Massachusetts nonprofit organiza-
tions,wereunlikelybutalsounnecessaryinordertoadvancetheDA&O
model.Amorepracticalapproach,theysuggested,istoencouragenon-
profitinstitutionstocompensatemedicalinjuriesatafairvalue,regard-
lessofanylegalinsulationfromlargeawardsattrial.Sincethecharitable
immunitylawdoesnotaffectsettlements,hospitalscould(andoftendo)
choose to offer compensation above the cap, out of a sense of fairness,
Disclosure,Apology,andOfferPrograms 691
d
TABLE4BarrierstoImplementingDA&OModel IllustrativeQuotations Youdon’tnecessarilyneedtotakecharitableimmunityawaytomakeaprogramlikethisfly.Whatyouneedtodoisconvincetheinstitutionstowaivetheircharitableimmunityandtakesystems-levelresponsibility.”—AhospitalrepresentativeDisclosureisnotamateurhour.Itrequiresacertainlevelofexpertise.”—AphysicianTheybelievetheyaredoingGod’sworkinprotectingpatients,andtheygetpaidhandsomelyforthat.Thisisgoingtoaffecttheirpocketbook,andit’sgoingtoaffecttheirlivelihood.”—AhealthinsurerrepresentativeWemightnothaveenoughtimetogeteverybodytogether,togeteverybodytoassesswhat’sgoingonandthenmakeadetermination.Inthemeantime,thepatientisstillsittingthere.”—AhealthinsurerrepresentativeThesystemsissuesarebiggerthanthedoctorissuesinmostcases,soit’shardtosay,‘Doctor,you’retheonewho’sgoingtogettheding,’whenweknowitwasn’t[his/herfault].”—Aphysicianrepresentativeofacommunity/teachinghospitalIthinkthatthereareconcernsonthepartofthephysicianthatevenwithawell-vettedmodellikethis,thatitmaystillexposethemtogreatermalpracticeliability.Ithinktherearemanywhofeelthatiftheyjustdon’tcomeforward,maybethepatientwon’tnoticeorwon’tdoanythingortakeanyfurtheractions.”—AhealthinsurerrepresentativeWell,it’schange!It’sbigchange.Allthetraditionalimpedimentstoanychangewouldcertainlybeinforcehere.”—Ahospitalrepresentative Continue
“ “ “ “ “ “ “
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(n) 2/2 1/2 0/2 0/2 9/2 6/2 3/2
% (2 (2 (2 (2 (1 (1 (1
1 8 4 4 0 9 8
8 7 7 7 7 5 4
h rs
t e
BarrierCited Charitableimmunity Physicians’discomfortwidisclosureAttorneys’interestinmaintainingthestatusquoCoordinationacrossinsur Physicians’name–basedreporting Concernaboutincreasedliability Forcesofinertia